Trazodone in Everyday Care for Depression With Mild Memory and Thinking Problems
Follows how people with major depressive disorder and mild cognitive impairment respond to trazodone.
Plain-language title generated from the registry record
Registry title: Real-world Clinical Response to Trazodone in Italy, Poland, and Romania
Key facts
- Where
- Lodz, PolandSee the site
Where in Poland
- Poradnia Medycyna Miłorząb: pl. Pokoju 3/4, 90-227 Łódź. PolandLodz, PolandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Trial code
- NCT07377682
- Record updated
- 30 January 2026
- Original description
TRACOMDD study is a study with the intention to describe the real-world use of trazodone and the clinical response in a sub-group of patients affected by Major Depressive Disorder and Mild Cognitive impairment, by collecting data from standard clinical practice in Italy, Poland, and RomaniaRead full original descriptionShow less
Observational Prospective Study in Patients With Major Depressive Disorder and Mild Cognition Impairment Treated With Trazodone in a Real-world Setting (TRACOMDD)
TRACOMDD study is a study with the intention to describe the real-world use of trazodone and the clinical response in a sub-group of patients affected by Major Depressive Disorder and Mild Cognitive impairment, by collecting data from standard clinical practice in Italy, Poland, and Romania
Inclusion: Patients aged 55 or older; Patients who meet the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for MDD diagnosis; Patients experiencing a current major depressive episode of at least moderate severity, defined by a Montgomery Åsberg Depression Rating Scale (MADRS) total score ≥20 at enrolment; Patients with a diagnosis of MCI (also referred to as "mild neurocognitive disorder") according to the DSM-5 criteria; Patients who start treatment with trazodone hydrochloride (prolonged release) with starting dosage according to SmPC at enrolment visit (or at latest within one week); Patients legally capable of giving their written consent to participate in the study (including personal data processing) and willing to comply with all study procedures as per clinical judgement.
Exclusion: Concomitant treatment with other antidepressant drugs, mood stabilizers, antipsychotics, and/or proved resistance to trazodone monotherapy; Patients with previous or current history of any neurological condition that, in the opinion of the Investigator, might compromise participation in the study; Patients participating in any interventional study in the 30 days prior to the enrolment visit; Known hypersensitivity or allergy to the active ingredient and/or to any component of the study medication; Patients with current diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, severe personality disorder, mental retardation, organic mental disorders, or mental disorders due to a general medical condition; Patients who meet any of the contraindications to the administration of trazodone according to the approved local SmPC; Patients with ongoing pregnancy or breast-feeding at enrolment visit.